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510(k) Data Aggregation
(25 days)
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:
- Pressure ulcers
- Leg ulcers
- Diabetic ulcers
- Graft and donor sites
- Post-operative surgical wounds
- Trauma wounds (dermal lesions, trauma injuries or incisions)
- 1st and 2nd degree burns
- Abrasions and lacerations
Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing. Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel. Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.
The provided text is a 510(k) summary for a medical device modification, specifically for a Silver Antimicrobial Wound Gel. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not include specific acceptance criteria with quantifiable metrics (e.g., "device must achieve X% sensitivity or Y% specificity"). Instead, it focuses on demonstrating performance through qualitative statements and comparisons.
Therefore, for the requested table of acceptance criteria and device performance, I can only extract what is stated. For other sections, the information is largely absent based on a typical AI/software device study description.
Here's the analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a device modification for a wound care product, not an AI software), the "acceptance criteria" are not presented as numerical thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating antimicrobial barrier activity and acceptable wound healing performance compared to a predicate device and standard care.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| In-vitro Antimicrobial Barrier Activity | Effective against: Staphylococcus aureus (including MRSA), Staphylococcus epidermidis (including MRSE), Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus brasiliensis (formerly Aspergillus niger) when they come into contact with the gel. Demonstrated by a seven-day log reduction evaluation test and preservative efficacy test (USP 33 <51> and European Pharmacopoeia Edition 6.6 section 5.1.3). The clinical implications of the in-vitro findings are unknown. |
| Biocompatibility | Compliant with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). |
| In-vivo Wound Closure Rate (compared to predicate/control) | "The report findings showed that the rate of wound closure in receipt of Silver Antimicrobial Wound Gel showed no significant differences when compared to the Hydrogel and 'Wet to Dry' gauze treatment." |
| In-vivo Wound Adherence (compared to predicate/control) | "Wound site adherence...was not detected for the Silver Antimicrobial Wound Gel or Hydrogel at any point in the study" (significant in "Wet to Dry" gauze treated wounds). This indicates better performance than "Wet to Dry" gauze. |
| In-vivo Peri-wound Inflammation/Erythema | "Peri-wound inflammation/erythema was less frequently observed and less severe in Silver Antimicrobial Wound Gel and Hydrogel treated wounds than in similar control 'Wet to Dry gauze' treated wounds." This indicates better performance than "Wet to Dry" gauze. |
| In-vivo Adverse Effects | "No adverse effects were noted following the use of either of the Silver Antimicrobial Wound Gel or the Hydrogel 'dressings' investigated." |
| Substantial Equivalence to Predicate Device (K073197) | "The Silver Antimicrobial Wound Gel...is substantially equivalent to Advanced Medical Solutions Limited's Antimicrobial Wound Gel, 510(k) # K073197." This is the overarching acceptance criterion for the 510(k) submission. Demonstrated through the above testing, biocompatibility, and antimicrobial activity. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of subjects or wounds for the in-vivo porcine study. It only mentions "an in-vivo porcine study."
- Data Provenance: The in-vivo study was a porcine study (animal model). The country of origin for the data is not specified, but the applicant is based in the United Kingdom. It is a prospective study as it describes an assessment over time ("day 2 & 4 assessment points").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. The in-vivo study involved direct observation and measurement of wound characteristics in a porcine model, rather than expert interpretation of images or clinical data for ground truth establishment in the way an AI medical device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in clinical image interpretation, not for direct observations in an animal model.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a wound care gel.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a wound care gel, not an algorithm. Therefore, "standalone" performance in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the in-vivo study, the "ground truth" (or outcome measures) were direct observations of wound closure rate, wound site adherence, peri-wound inflammation/erythema, presence of debris, and adverse effects in a porcine model. These are direct physical measurements and observations.
- For the in-vitro study, the ground truth was based on laboratory testing against specified microorganisms following recognized standards (USP 33 <51> and European Pharmacopoeia Edition 6.6 section 5.1.3).
8. The sample size for the training set
- Not applicable. This is a medical device (wound gel), not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this device.
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(289 days)
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:
- . Pressure ulcers
- Leg ulcers .
- . Diabetic ulcers
- . Graft and donor sites
- . Post-operative surgical wounds
- . Trauma wounds (dermal lesions, trauma injuries or incisions)
- 1st and 2nd degree burns .
- Abrasions and lacerations .
Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing.
Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel.
Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Silver Antimicrobial Wound Gel":
The document does not explicitly state numerical acceptance criteria in a table format for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to established in-vitro and in-vivo testing standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (a 510(k) for a wound gel), the "acceptance criteria" are more implicitly derived from demonstrating safety, efficacy, and substantial equivalence to existing predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Antimicrobial Barrier Activity (In-vitro) | Effective against Staphylococcus aureus (including MRSA), Staphylococcus epidermidis (including MRSE), Streptoccus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus niger when they come into contact with the gel. Demonstrated by 7-day log reduction and preservative efficacy test (USP 30 <51>). |
| Biocompatibility | Demonstrated to be in compliance with BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). No adverse effects noted in the in-vivo study. |
| Wound Closure Rate (In-vivo) | No statistically significant differences in the rate of wound closure when compared to a similar hydrogel (without silver) and "Wet to Dry" gauze. |
| Wound Site Adherence (In-vivo) | Not detected for the device, similar to the comparative Hydrogel, and significantly better than "Wet to Dry" gauze. |
| Peri-wound Inflammation/Erythema (In-vivo) | Less frequently observed and less severe than in "Wet to Dry gauze" treated wounds, similar to the comparative Hydrogel. |
| No Adverse Effects (In-vivo) | No adverse effects were noted following the use of the Silver Antimicrobial Wound Gel. |
| Manufacturing Quality | Manufactured according to product specification and Good Manufacturing Practices (GMP). Risk analysis performed and controls implemented. |
| Substantial Equivalence to Predicate Devices | The indication for use, performance testing, and antimicrobial activity are substantially equivalent to "Silver Shield™ Antimicrobial Skin and Wound Gel" (K062212) and "AcryDerm Silver Antimicrobial Wound Gel" (K011994, K070333). |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily references two types of testing for device performance:
-
In-vitro Testing:
- Sample Size: Not explicitly stated as a numerical count of "samples" for the antimicrobial tests. It mentions a "seven day log reduction evaluation test and preservative efficacy test in accordance with the requirements of USP 30 <51> (Antimicrobial Effectiveness Testing)." This implies standardized methodology with defined replicates, but not a specific "sample size" in terms of clinical cases.
- Data Provenance: Not specified, but generally, in-vitro tests are conducted in laboratory settings, likely within the UK or a qualified testing facility.
-
In-vivo Testing (Porcine Study):
- Sample Size: Not explicitly stated as a number of animals or wounds. The wording describes "an in-vivo porcine study" that assessed dressing performance and compared three treatment arms (Silver Antimicrobial Wound Gel, equivalent Hydrogel without silver, and "Wet to Dry" gauze). We cannot determine the exact sample size from the provided text.
- Data Provenance: The study was "in-vivo," using porcine subjects, implying a controlled animal study. The country of origin for the study is not mentioned. It is a prospective study as it involved applying the treatments and then assessing outcomes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- In-vitro Testing: Not applicable in the context of "experts establishing ground truth." The ground truth for antimicrobial efficacy is derived from standardized laboratory tests with defined protocols (e.g., USP 30 <51> requirements).
- In-vivo Testing (Porcine Study): Not explicitly stated. For animal studies, assessments would typically be performed by trained researchers or veterinary professionals. It does not mention a panel of "experts" in the context of radiologists or similar clinical specialties for establishing ground truth, as this is an animal study evaluating wound healing parameters.
4. Adjudication Method for the Test Set
- In-vitro Testing: Not applicable. Results are quantitative measurements from lab tests.
- In-vivo Testing (Porcine Study): Not specified. The document states "The report findings showed that..." suggesting data collection and analysis, but no explicit adjudication method (like 2+1 or 3+1 consensus) among multiple assessors for qualitative observations is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study typically involves multiple human readers evaluating medical images or cases with and without AI assistance to measure reader improvement. The provided document concerns a wound gel and its performance, not an AI-based diagnostic or assistive device for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study in the context of an algorithm's performance was not conducted. The device is a wound gel, which is a physical product, not a software algorithm. Its performance is intrinsic to its physical and chemical properties and how it interacts with wounds, not through an algorithm operating independently.
7. Type of Ground Truth Used
- In-vitro Testing: Ground truth is established by standardized laboratory test results (e.g., log reduction of microbial counts for antimicrobial efficacy, compliance with ISO standards for biocompatibility).
- In-vivo Testing (Porcine Study): Ground truth is based on direct observation and measurement of wound healing parameters in a controlled animal model. This includes wound closure rate, wound site adherence, peri-wound inflammation/erythema, and general absence of adverse effects.
8. Sample Size for the Training Set
Not applicable. This device is a wound care product, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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